The aim of this methods project is to compare the relative performance of three analytic methods, TreeScan, Sequence Symmetry Analysis (SSA), and Information Component Temporal Pattern Discovery (ICTPD) in signal detection capability (both type I and type II error) using a simulated dataset as well as concordance in alerting when using an empiric dataset. The Workgroup will use the same dataset(s) to examine health outcomes of interest using all three methods.

The Workgroup will select at least one drug evaluation example with a well-known safety profile for evaluation of TreeScan, SSA, and ICTPD.

For the primary analysis the Workgroup will use the CDER-curated Multi-Level Clinical Classification Software (MLCCS) outcome tree. This tree contains thousands of hierarchically grouped adverse events based on International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes. For the secondary analysis the Workgroup will scan the same outcomes defined by a single ICD-9-CM diagnosis code, i.e. absent any clinically related groupings.

This protocol was posted for public comment from November 30, 2018 through December 28, 2018. The public comment period is now closed.